Liver FailureNCT06300372
Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors
A study testing M-TAPA plane block and Postoperative pain management in people with Liver Failure and Acute Postoperative Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Failure, Acute Postoperative Pain
- What is being tested?
- M-TAPA plane block and Postoperative pain management
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- with history of bleeding diathesis,
- receiving anticoagulant treatment,
- with allergies or sensitivity to drugs used,
- with an infection on the puncture site
- who do not accept the procedure or participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Mega Hospital Complex
Istanbul, Bagcilar
About this study
Official title: Ultrasonography-Guided Bilateral Modified Thoracoabdominal Nerve Plane Block With Perichondrial Approach (M-TAPA) For Postoperative Pain Management In Living Liver Donors: Randomized Controlled Study.
Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. As there are studies showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.
Read the detailed description
Open hepatic resection for living liver transplantation donor surgery can cause severe postoperative pain and if not treated properly, may increase the risk of chronic pain development, which has a significant impact on the patient's daily life quality. The use of interfascial plane blocks for pain control has increased in recent years, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia. Additionally, reducing postoperative opioid consumption may be a useful strategy to provide hemodynamic stability and promote early mobilization. Case reports state interfascial plane blocks to be effective and safe for providing effective analgesia compared to systemic analgesia in living liver donor surgeries. As studies are showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that the M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.
- Conditions
- Liver Failure, Acute Postoperative Pain
- Being tested
- M-TAPA plane block, Postoperative pain management
- Keywords
- Modified Thoracoabdominal Nerve Plane Block, Liver Transplantation, Acute Postoperative Pain
- Medical subject headings
- Liver Failure, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TAPA plane blockProcedure or surgery
As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Pajunk Sonoplex Nanoline Stim Cannula, Germany) will be placed in a sagittal position at the costochondral junction at the level of the 9th and 10th ribs. After the rib and the external oblique, internal oblique, and transversus abdominis muscles are visualized on USG, using an in-plane technique, the block needle will be advanced and the block location will be confirmed by injecting 5 ml of saline between the internal oblique and transversus abdominis muscles. Once the block location is confirmed, 30 ml of 0.25% bupivacaine (Buvicaine ®) will be applied bilaterally (60 ml in total).
Postoperative pain managementProcedure or surgery
For preemptive analgesia, morphine (Morfin ®) 0.05mg/kg and Ibuprofen 400mg IV (Ibuprofen®) will be administered to all patients before the surgical incision. An additional dose of ibuprofen 400mg IV, meperidine (Aldolan ®), and tramadol (Contramal®) 1mg/kg IV will be administered to all patients 30 minutes before wound closure.10 mcg/ml fentanyl containing PCA will be connected to all patients without infusion and boluses 0,35 mcg/kg,15-minute lockout period, maximum 100 mcg per hour. Postoperative patient evaluation will be performed by another anesthesiologist. If the NRS score is ≥ 4, 0.5 mg/kg IV meperidine (Aldolan®)will be administered as a rescue analgesic.
| Study group | Role | What they receive |
|---|---|---|
| Group A=M-TAPA block group | Experimental | M-TAPA plane block will be performed and standard postoperative pain management protocols will be applied. Receives: Procedure: M-TAPA plane block; Procedure: Postoperative pain management |
| Group B = control group | Active comparator | Only standard postoperative pain management protocols will be applied. No plane blocks will be applied Receives: Procedure: Postoperative pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption (Fentanyl PCA)
The primary aim is to compare postoperative opioid consumption from the PCA device.
Measured: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours
Secondary outcomes (3)
Pain scores (Numerical rating scale-NRS
The secondary aim is to compare NRS at the postoperative 48 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded.
Measured: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours]
Need for rescue analgesia (meperidine)
The secondary aim is to compare rescue analgesia used in the postoperative 48 h.
Measured: Postoperative 48 hours period
Adverse events
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.
Measured: Postoperative 48 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Apr 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fifty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II, scheduled for living liver donation surgery for liver transplantation will be included in the study. Patients will be randomly divided into two groups (Group A=M-TAPA block group, Group B = control group) including 25 patients each, before entering the operating room.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ince, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300372
- Sponsor's protocol ID
- Medipol Hospital 2
- Status last verified
- Jan 2025
- First submitted
- 3 Mar 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share individual patient data(IPD)
Publications
Yong BH, Tsui SL, Leung CC, Lo CM, Liu CL, Fan ST, Young K. Management of postoperative analgesia in living liver donors. Transplant Proc. 2000 Nov;32(7):2110. doi: 10.1016/s0041-1345(00)01592-x. No abstract available.
PubMed 11120091Hacibeyoglu G, Topal A, Arican S, Kilicaslan A, Tekin A, Uzun ST. USG guided bilateral erector spinae plane block is an effective and safe postoperative analgesia method for living donor liver transplantation. J Clin Anesth. 2018 Sep;49:36-37. doi: 10.1016/j.jclinane.2018.06.003. Epub 2018 Jun 5. No abstract available.
PubMed 29883965Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.
PubMed 20830871Tulgar S, Senturk O, Selvi O, Balaban O, Ahiskalioglu A, Thomas DT, Ozer Z. Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:8-10. doi: 10.1016/j.jclinane.2018.10.015. Epub 2018 Oct 31. No abstract available.
PubMed 30388604Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.
PubMed 30639940Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available.
PubMed 31212124Gungor H, Ince A, Ciftci B, Emre Golboyu B, Asici M, Karaaslan P, Yanaral TU. Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach for Postoperative Analgesia Management in Living Liver Donors: A Randomized, Prospective, Controlled Study. Clin Transplant. 2025 Sep;39(9):e70224. doi: 10.1111/ctr.70224.
PubMed 40892532
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography-Guided Bilateral Modified Thoracoabdominal Nerve Plane Block With Perichondrial Approach (M-TAPA) For Postoperative Pain Management In Living Liver Donors: Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06300372
- Acronym / sponsor ID
- Medipol Hospital 2
- Conditions
- Liver Failure, Acute Postoperative Pain
- Keywords
- Modified Thoracoabdominal Nerve Plane Block, Liver Transplantation, Acute Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. As there are studies showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.
Detailed description
Open hepatic resection for living liver transplantation donor surgery can cause severe postoperative pain and if not treated properly, may increase the risk of chronic pain development, which has a significant impact on the patient's daily life quality. The use of interfascial plane blocks for pain control has increased in recent years, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia. Additionally, reducing postoperative opioid consumption may be a useful strategy to provide hemodynamic stability and promote early mobilization. Case reports state interfascial plane blocks to be effective and safe for providing effective analgesia compared to systemic analgesia in living liver donor surgeries. As studies are showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that the M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Fifty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II, scheduled for living liver donation surgery for liver transplantation will be included in the study. Patients will be randomly divided into two groups (Group A=M-TAPA block group, Group B = control group) including 25 patients each, before entering the operating room.
| Arm | Type | Receives |
|---|---|---|
| Group A=M-TAPA block group | Experimental | Procedure: M-TAPA plane block, Procedure: Postoperative pain managementM-TAPA plane block will be performed and standard postoperative pain management protocols will be applied. |
| Group B = control group | Active comparator | Procedure: Postoperative pain managementOnly standard postoperative pain management protocols will be applied. No plane blocks will be applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- with history of bleeding diathesis,
- receiving anticoagulant treatment,
- with allergies or sensitivity to drugs used,
- with an infection on the puncture site
- who do not accept the procedure or participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-TAPA plane blockAs the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Pajunk Sonoplex Nanoline Stim Cannula, Germany) will be placed in a sagittal position at the costochondral junction at the level of the 9th and 10th ribs. After the rib and the external oblique, internal oblique, and transversus abdominis muscles are visualized on USG, using an in-plane technique, the block needle will be advanced and the block location will be confirmed by injecting 5 ml of saline between the internal oblique and transversus abdominis muscles. Once the block location is confirmed, 30 ml of 0.25% bupivacaine (Buvicaine ®) will be applied bilaterally (60 ml in total). | Procedure or surgery | Group A=M-TAPA block group |
| Postoperative pain managementFor preemptive analgesia, morphine (Morfin ®) 0.05mg/kg and Ibuprofen 400mg IV (Ibuprofen®) will be administered to all patients before the surgical incision. An additional dose of ibuprofen 400mg IV, meperidine (Aldolan ®), and tramadol (Contramal®) 1mg/kg IV will be administered to all patients 30 minutes before wound closure.10 mcg/ml fentanyl containing PCA will be connected to all patients without infusion and boluses 0,35 mcg/kg,15-minute lockout period, maximum 100 mcg per hour. Postoperative patient evaluation will be performed by another anesthesiologist. If the NRS score is ≥ 4, 0.5 mg/kg IV meperidine (Aldolan®)will be administered as a rescue analgesic. | Procedure or surgery | Group A=M-TAPA block group, Group B = control group |
Primary outcome
Opioid consumption (Fentanyl PCA)
Time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours
The primary aim is to compare postoperative opioid consumption from the PCA device.
3 secondary outcomes
Pain scores (Numerical rating scale-NRS
Time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours]
Need for rescue analgesia (meperidine)
Time frame: Postoperative 48 hours period
Adverse events
Time frame: Postoperative 48 hours period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Background: PubMed 11120091Yong BH, Tsui SL, Leung CC, Lo CM, Liu CL, Fan ST, Young K. Management of postoperative analgesia in living liver donors. Transplant Proc. 2000 Nov;32(7):2110. doi: 10.1016/s0041-1345(00)01592-x. No abstract available.
- Background: PubMed 29883965Hacibeyoglu G, Topal A, Arican S, Kilicaslan A, Tekin A, Uzun ST. USG guided bilateral erector spinae plane block is an effective and safe postoperative analgesia method for living donor liver transplantation. J Clin Anesth. 2018 Sep;49:36-37. doi: 10.1016/j.jclinane.2018.06.003. Epub 2018 Jun 5. No abstract available.
- Background: PubMed 20830871Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.
- Background: PubMed 30388604Tulgar S, Senturk O, Selvi O, Balaban O, Ahiskalioglu A, Thomas DT, Ozer Z. Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:8-10. doi: 10.1016/j.jclinane.2018.10.015. Epub 2018 Oct 31. No abstract available.
- Background: PubMed 30639940Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.
- Background: PubMed 31212124Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available.
- Derived from this study: PubMed 40892532Gungor H, Ince A, Ciftci B, Emre Golboyu B, Asici M, Karaaslan P, Yanaral TU. Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach for Postoperative Analgesia Management in Living Liver Donors: A Randomized, Prospective, Controlled Study. Clin Transplant. 2025 Sep;39(9):e70224. doi: 10.1111/ctr.70224.
- Individual participant dataSharing planned: No. The investigators will not share individual patient data(IPD)
Related trials for Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-TAPA plane block and Postoperative pain management in people with Liver Failure and Acute Postoperative Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (Fentanyl PCA) (time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06300372, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.